On March 10, 2016, Health Canada released a Draft Guidance Document – Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act for consultation.
As part of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), pparagraph 21.1(3)(c) of the Food and Drugs Act was amended to give the Minister of Health the discretion to disclose confidential business information (CBI) about a therapeutic product to eligible persons for the purpose of protecting or promoting human health or the safety of the public. The draft guidance document describes Health Canada’s implementation of the discretionary authority under paragraph 21.1(3)(c) by providing the broad principles, considerations and processes that Health Canada will use when deciding whether or not to disclose CBI (Health Canada’s news release can be found here). The deadline for comments is May 24, 2016.
Past E-TIPS® Newsletter commentaries on Vanessa’s Law can be found here and here.
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